ADIA is the peak business organisation representing manufacturers and suppliers of dental products. Our vision is for an industry that empowers oral health professionals to advance the health and wellbeing of all Australians......................— ADIA Strategic Plan

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TGA’s Caution To Those Buying Online From Overseas

9th May 17

Summary —

The Therapeutic Goods Administration's (TGA) advice to dental professionals seeking to buy dental products from overseas then use them on patients is to avoid doing so, as it is a criminal offence under the Therapeutic Goods Act 1989 to import into, as it is a criminal offence under the Therapeutic Goods Act (Cth) 1989 to import then supply or use a medical device that has not been entered onto the Australian Register of Therapeutic Goods (ARTG).

Key Issues For The Dental Industry —

The TGA regulates all medical devices that are imported into, supplied in or exported from Australia under the Therapeutic Goods Act 1989 (the Act).

Unless a specific exemption applies, under the Act medical devices must be included on the ARTGbefore they can be supplied in Australia.

It’s not uncommon for dental professionals to consider buying dental products from websites overseas with a view to using them on patients within Australia. The TGA’s caution to such professionals is be careful and the regulator has issues guidance on some commonly asked questions:

Can health professionals import medical devices for use in their clinical practice?

Yes, but to do so results in health professionals being subject to therapeutic goods regulations. Health professionals who import medical devices for use in their clinical practice are considered to be supplying the devices to the general public.

Examples of importing medical devices include purchasing from overseas through the internet or from mail order catalogues, or obtaining from international conferences and trade exhibits.

Does use in clinical practice really mean supply of a medical device?

Yes, the term 'supply' is defined in section 3 of the Act and does include supply to mean by way of administration to, or application in the treatment of, a person

Other definitions about supply of therapeutic goods includes: The supply by way of sale, exchange, gift, lease, loan, hire or hire-purchase; Supply, whether free of charge or otherwise, by way of sample or advertisement; and Supply, whether free of charge or otherwise, in the course of testing the safety or efficacy of therapeutic goods in person.

When importing a device already included on the ARTG, does another application need to be made to the TGA?

Each ARTG entry is unique to the sponsor, manufacturer and the kind of device. Therefore, every sponsor needs to apply to the TGA to have their imported medical devices included on the ARTG, even if another sponsor already has an ARTG entry for the same device.

What are the responsibilities of health professionals who supplies medical devices?

If a dental professional supplies a medical device to the Australian market, including by using it in their clinical practice, they become the “sponsor” of the device. The sponsor is the person who becomes legally responsible for the devices they import into the country (even if somebody else is already importing the same product) and they must comply with all regulatory requirements as sponsors including:

Applying to the TGA to have each kind of medical device included on the ARTG

Ensuring the device continues to meet all legislative requirements once on the market

Record keeping about medical devices supplied

Reporting any adverse events or problems

Taking corrective or preventative action, such as recalls, if necessary.

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Furthermore, when dental professionals become the sponsor of a medical device, it is part of their obligations to fulfil the manufacturer's warranty and provide maintenance and servicing where required. It is important that health professionals who are sponsors understand that a condition of inclusion on the ARTG is that medical devices continue to meet all the relevant Essential Principles for safety and performance.

What are the penalties that dental professionals face for breaching the legislation?

Dental professionals who do not comply with the import and supply regulations for medical devices could face civil or criminal penalties of up to five years imprisonment and / or 5000 penalty units, with one penalty unit is $210 from 1 July 2017 under the Crimes Act (Cth) 1914. That's a fine of up to $1,050,000! Offences include:

Supplying therapeutic goods not included on the ARTG

Importing and/or supplying medical devices that do not meet the required design and performace standards.

Failing to apply conformity assessment procedures (for more information see the Australian regulatory guidelines for medical devices)

Misrepresenting medical devices

Failing to report adverse events.

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It’s for this reason that the TGA urges all dental and oral healthcare professionals who are thinking about importing dental products from overseas to carefully consider all of their issues.

Dental professionals importing products from overseas with an intent of using these products on their patients and / or selling them (without placing products on the ARTG) have other concerns to worry about. A breach of the TGA’s regulation jeopardises a dental professionals registration with the Dental Board of Australia (DBA) as it is a DBA requirement that all legislation relevant to the practice of dentistry be complied with which encompasses compliance with the Therapeutic Goods Act (Cth) 1989. The insurance policies held by many dental professionals will be invalidated if a claim arises associated with the use of dental products that were not place on the ARTG when there is a need to do so.

Member Engagement —

On matters associated with dental product regulation, the team in the ADIA national office receive advice and guidance from members serving on the ADIA-DRC Dental Regulation Committee. Updates on the research are provided at the quarterly ADIA State Branch Briefings. If your business has an interest in this matter, get involved today.

This update was issued on 9 May 2017 and please note that changes in circumstances after the publication of material or information may impact upon its accuracy and also change regulatory compliance obligations. The statements, regulatory and technical information contained herein are believed to be accurate and are provided for information purposes only. Readers are responsible for assessing its relevance and verifying the accuracy of the content. To the fullest extent permitted by law, ADIA will not be liable for any loss, damage, cost or expense incurred in relation to or arising as a result of relying on the information presented here. .

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